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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceELASTIMIDE(TM) SILICONE MODIFIED J-LOOP POST. CHAM
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
STAAR SURGICAL CO.
1911 walker ave.
monrovia, CA 91016
PMA NumberP900048
Date Received07/02/1990
Decision Date09/17/1991
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 91M-0376
Notice Date 10/11/1991
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 
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